Inhibikase Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 10, 2026
IKT$1.55-7.7%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-344707
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001193125-26-455625
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 116 previous paragraphs and 108 current paragraphs.
64 unchanged; 34 reworded; 9 added; 18 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
In October 2026, we announced the appointment of Scott M. Wasserman, M.D., to our board of directors, effective October 19, 2026. Concurrent with Dr. Wasserman’s appointment, Dennis Berman resigned from our board of directors.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
On September 10, 2026, we received $1.0 million related to the exercise of 730,000 Series A-1 Warrants.
Current report
Net cash flows provided by financing activities for the nine months ended September 30, 2026, totaled $53,340,356, which consisted of $52.0 million of net proceeds from the issuance of common stock under the Sales Agreement, $1.0 million from the exercise of Series A-1 Warrants, and $0.3 million of net proceeds from the issuance of common stock related to exercise of stock options.
Current report
The preparation of financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and related disclosures in the financial statements. Management considers an accounting estimate to be critical if:
Current report
it requires assumptions to be made that were uncertain at the time the estimate was made, and
Current report
changes in the estimate or different estimates that could have been selected could have a material impact in our results of operations or financial condition.
Current report
While we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances, actual results could differ from those estimates, and the differences could be material. For a discussion of the critical accounting estimates that affect the unaudited condensed consolidated financial statements, see “Critical Accounting Estimates” included in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report.
Current report
See Note 3 to our unaudited condensed consolidated financial statements for a discussion of our significant accounting policies.
Removed paragraphs (18)
Previous report
In May 2026, pre-clinical and Phase 1 data for IKT-001 were presented at the American Thoracic Society International Conference in Orlando, Florida. These presentations demonstrated the potential for IKT-001 to have an improved gastro-intestinal (“GI”) side-effect profile, including gastric emptying benefits and reduced impairment of intestinal motility compared to imatinib mesylate. IKT-001 remains intact in the stomach and the intestine and is not converted to imatinib until it reaches the blood, with in vitro pharmacology studies demonstrating an 18-fold decrease, relative to imatinib, in c-Kit inhibition which has been implicated in the GI side-effects of imatinib. Additionally, single doses of IKT-001 resulted in rapid and dose proportional exposure to circulating imatinib, which were well tolerated over a 300-800 mg range with no indication of dose-dependent GI toxicities.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
Cash Provided by Financing Activities
Previous report
Net cash flows provided by financing activities for the six months ended June 30, 2025, totaled $31,771, which consisted of net proceeds from the issuance of common stock related to option exercises and the exercise of pre-funded warrants issued in our registered direct offering and concurrent private placement that closed in May 2024.
Previous report
This discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in the notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Previous report
Research and Development Expenses
Previous report
We record research and development expenses to operations as incurred. Research and development expenses represent costs incurred by us for the discovery and development of our product candidates and prodrug technologies and include: employee-related expenses, such as salaries, benefits, travel and non-cash stock-based compensation expense; external research and development expenses incurred under arrangements with third parties, such as CROs, preclinical testing organizations, clinical testing organizations, CMOs, academic and non-profit institutions and consultants; costs to acquire technologies to be used in research and development that have not reached technological feasibility and have no alternative future use; license fees; and other expenses, which include direct and allocated expenses for laboratory, facilities and other costs.
Previous report
As part of the process of preparing the condensed consolidated financial statements, we are required to estimate and accrue expenses. A portion of our research and development expenses are external costs, which we track on a program-specific basis. We record the estimated expenses of research and development activities conducted by third party service providers as they are incurred and provided within research and development expense in the condensed consolidated statements of operations and comprehensive loss. These services include the conduct of preclinical studies and consulting services. These costs are a significant component of our research and development expenses. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating to intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Previous report
Costs for research and development activities are recognized based on costs incurred. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed may vary from our estimates and could result in us reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from external clinical research organizations and other third-party service providers. Due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trials and other research activities.
Previous report
Contingent Consideration Liabilities
Previous report
We evaluate acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.
Previous report
On February 21, 2025, we entered into an Agreement and Plan of Merger and Reorganization (“Merger Agreement”) with Project IKT Merger Sub, Inc., a Delaware corporation and our wholly-owned subsidiary and CorHepta. We determined that the transaction represented an asset acquisition as defined by ASC 805 as substantially all of the value was attributed to a single intangible asset, in-process research and development (“IPR&D”).
Previous report
The fair value was determined based on our share price at closing. We agreed to issue 4,979,101 shares of our common stock to the shareholders of CorHepta, of which (i) 829,849 shares were fully vested on the acquisition date, (ii) 2,489,030 shares represented contingent consideration and vested on February 21, 2026, upon the achievement of a service milestone, and (iii) 1,660,222 shares represented post-merger compensation expense, subject to both service- and performance-based vesting conditions, which were not met and, as a result, these shares were forfeited on February 21, 2026. Upon determination that the service milestone was satisfied in relation to (ii) above, the liability was settled through the issuance of common stock and reclassified to additional paid-in capital on February 21, 2026. No other agreements with contingent consideration currently exist.
Previous report
As of the acquisition date, the achievement of one of the contingent consideration milestones was deemed probable, and the fair value of the related shares was included in the purchase price of the acquisition. We remeasure the initial contingent consideration recognized at acquisition to fair value at each reporting date and recorded a change in fair value of $0 and $373,354 for the three and six months ended June 30, 2026, respectively which is included within operating expenses and $358,420 and $1,523,284 for the three and six months ended June 30, 2025, respectively, which is included within operating expenses. We recognized a contingent consideration liability and corresponding expense for the remaining contingent consideration shares in future periods when it was probable that a liability had been incurred and the amount of that liability could be reasonably estimated.
Previous report
The IPR&D had not reached technological feasibility and had no alternative future use at the acquisition date, and therefore, the acquired IPR&D asset of $7,357,294 was written off as research and development expense in our consolidated statements of operations and comprehensive loss immediately following the acquisition in accordance with ASC 730.
Previous report
Smaller Reporting Company Status
Previous report
Effective as of December 31, 2025, we no longer qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012. As such, we are subject to additional expenses that we did not previously incur in complying with the Sarbanes-Oxley Act of 2002 (“SOX”) and rules implemented by the SEC. We are also subject to certain disclosure requirements that are applicable to other public companies that were not applicable to us as an emerging growth company, for example, compliance with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the consolidated financial statements and compliance with the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
Previous report
However, we continue to qualify as a “smaller reporting company,” as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies. To the extent that we continue to qualify as a “smaller reporting company” as such term is defined in Rule 12b-2 under the Exchange Act, certain of the exemptions available to us as an “emerging growth company” continue to be available to us as a “smaller reporting company,” including exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive compensation arrangements. We will continue to be a “smaller reporting company” for so long as we have either (i) a public float of less than $250 million measured as of the last business day of our most recently completed second fiscal quarter, or (ii) annual revenue of less than $100 million during our most recently completed fiscal year and either no public float or a public float of less than $700 million measured as of the last business day of our most recently completed second fiscal quarter.
Reworded paragraphs (34)
Previous wording
We are a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension (“PAH”). Our lead product candidate, known as IKT-001, a prodrug of imatinib mesylate (“imatinib”), for PAH which is an orphan indication. Imatinib was first approved in the United States in 2001 for various cancers and blood disorders and, following more than 20 years of clinical use, has a well-characterized safety profile with the first reported use of imatinib in PAH occurring in 2005. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. We have completed a non-human primate safety study and a bioequivalence clinical study in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib. Our Phase 3 clinical study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), which is a single pivotal global study, is presently enrolling patients with 26 country regulatory approvals and 43 clinical sites activated to date, and 3 additional pending country regulatory approvals and 4 planned country regulatory submissions.
Current wording
We are a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension (“PAH”). Our lead product candidate, known as IKT-001, is a prodrug of imatinib mesylate (“imatinib”), for PAH which is an orphan indication. Imatinib was first approved in the United States in 2001 for various cancers and blood disorders and, following more than 20 years of clinical use, has a well-characterized safety profile with the first reported use of imatinib in PAH occurring in 2005. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. We have completed a non-human primate safety study and a bioequivalence clinical study in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib. Our Phase 3 clinical study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), which is a single pivotal global study, is presently enrolling patients with 28 country regulatory approvals globally and 79 clinical sites activated to date, and three additional pending country regulatory approvals and one planned country regulatory submission.
Previous wording
Following on from our submission of an Orphan Drug Designation (“ODD”) application to the U.S. Food and Drug Administration (the “FDA”) for IKT-001 for PAH in April 2026, FDA's Office of Orphan Products Development granted ODD for IKT-001 in July 2026. The grant of ODD applies to the active moiety of IKT-001, imatinib mesylate, rather than a specific formulation. ODD also provides potential development incentives, including eligibility for tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon regulatory approval.
Current wording
Following our submission of an Orphan Drug Designation (“ODD”) application to the FDA for IKT-001 for PAH in April 2026, the FDA's Office of Orphan Products Development granted ODD for IKT-001 in July 2026.The grant of ODD applies to the active moiety of IKT-001, imatinib mesylate, rather than a specific formulation. ODD also provides potential development incentives, including eligibility for tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon regulatory approval.
Previous wording
external research and development expenses, including expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”), preclinical testing organizations, clinical testing organizations, contract manufacturing organizations (“CMOs”), academic and non-profit institutions and consultants;
Current wording
external research and development expenses, including expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”), nonclinical testing organizations, clinical testing organizations, contract manufacturing organizations (“CMOs”), academic and non-profit institutions and consultants;
Previous wording
(1) The six months ended June 30, 2025 amount includes a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the acquisition of CorHepta Pharmaceuticals, Inc. (“CorHepta”).
Current wording
(1) The nine months ended September 30, 2025 amount includes a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the acquisition of CorHepta Pharmaceuticals, Inc. (“CorHepta”).
Previous wording
(2) Other research and development expenses include stock-based compensation expense of $1.5 million and $1.7 million for the three months ended June 30, 2026 and 2025, respectively, and $3.3 million and $2.1 million for the six months ended June 30, 2026 and 2025, respectively.
Current wording
(2) Other research and development expenses include stock-based compensation expense of $1.5 million and $1.7 million for the three months ended September 30, 2026 and 2025, respectively, and $4.8 million and $3.8 million for the nine months ended September 30, 2026 and 2025, respectively.
Previous wording
Research and development expenses increased by $8,122,497, or 154.1%, to $13,393,464 from $5,270,967 in the prior comparable period. The $8.1 million increase in research and development expenses was primarily due to an increase of $8.9 million in PAH expenses partially offset by a decrease of $0.8 million in other research and development.
Current wording
Research and development expenses increased by $7,350,169, or 96.1%, to $14,999,866 from $7,649,697 in the prior comparable period. The $7.4 million increase in research and development expenses was primarily due to an increase of $7.0 million in PAH expenses associated with the advancement of our single pivotal Phase 3 study for IKT-001 in PAH. There was also a net increase of $0.7 million in other research and development partially offset by a decrease of $0.3 million in the risvodetinib program, which was discontinued and out-licensed during the second quarter of 2025.
Previous wording
Selling, general and administrative expenses increased by $3,864,632, or 34.6%, to $15,033,654 from $11,169,022 in the prior comparable period. The $3.9 million increase was primarily driven by an increase of $3.5 million in stock-based compensation expense, an increase of $0.1 million in personnel-related costs, and an increase of $0.4 million in other expenses, partially offset by a $0.2 million decrease in legal, consulting and compliance costs.
Current wording
Selling, general and administrative expenses increased by $1,617,688 or 28.8%, to $7,229,191 from $5,611,503 in the prior comparable period. The $1.6 million increase was primarily driven by a $1.1 million increase in stock-based compensation expense, an increase of $0.4 million in personnel-related costs, and an increase of $0.1 million in other expenses.
Previous wording
Change in fair value contingent consideration decreased by $358,420 or 100%, to $0 from $358,420 in the prior comparable period. The decrease is a result of the change in fair value of the contingent consideration related to the CorHepta transaction from March 31, 2025 to June 30, 2025. The service milestone was satisfied and the contingent liability settled on February 21, 2026.
Current wording
Change in fair value contingent consideration decreased by $492,827 or 100%, to $0 from $492,827 in the prior comparable period. The decrease is a result of the change in fair value of the contingent consideration related to the CorHepta transaction from March 31, 2025 to September 30, 2025. The service milestone was satisfied and the contingent liability settled on February 21, 2026.
Previous wording
Other income increased by $543,009 or 59.2% to $1,459,764 from $916,755 in the prior comparable period. The increase was driven by an increase in interest earned on our cash, cash equivalents and marketable securities.
Current wording
Other income increased by $923,630 or 110.2% to $1,761,723 from $838,093 in the prior comparable period. The increase was driven by an increase in interest earned on our cash, cash equivalents and marketable securities.
Previous wording
Research and development expenses increased by $8,448,068, or 53.5%, to $24,232,614 from $15,784,546 in the prior comparable period. The prior period included a $7.4 million non-cash charge allocated to PAH related to the CorHepta transaction, which did not recur in the current period. Excluding the impact of this prior period charge, the increase in research and development was primarily driven by an increase in PAH costs associated with the Company's Phase 3 clinical study. There was also a net increase of $0.4 million in other research and development partially offset by a decrease of $0.2 million in the risvodetinib program, which has been discontinued and out licensed.
Current wording
Research and development expenses increased by $15,798,237, or 67.4%, to $39,232,480 from $23,434,243 in the prior comparable period. The prior period included a $7.4 million non-cash charge allocated to PAH related to the CorHepta transaction, which did not recur in the current period. Excluding the impact of this prior period charge, the increase in research and development was primarily driven by an increase in PAH costs associated with our single pivotal Phase 3 clinical study. There was also a net increase of $1.1 million in other research and development, primarily due to stock-based compensation, partially offset by a decrease of $0.5 million in the risvodetinib program, which was discontinued and out-licensed during the second quarter of 2025.
Previous wording
Selling, general and administrative expenses increased by $1,737,800 or 29.4%, to $7,657,531 from $5,919,731 in the prior comparable period. The $1.7 million increase was primarily driven by a $1.3 million increase in stock-based compensation expense, an increase of $0.4 million in legal, consulting and compliance costs, and an increase of $0.3 million in other expenses, partially offset by a decrease of $0.2 million in personnel-related costs.
Current wording
Selling, general and administrative expenses increased by $5,482,320, or 32.7%, to $22,262,845 from $16,780,525 in the prior comparable period. The $5.5 million increase was primarily driven by an increase of $4.6 million in stock-based compensation expense due primarily to additional equity grants to retain employees given the acceleration of our Phase 3 clinical study, an increase of $0.6 million in personnel-related costs, and an increase of $0.5 million in other expenses, partially offset by a $0.2 million decrease in legal, consulting and compliance costs.
Previous wording
Change in fair value contingent consideration decreased by $1,149,930, or 75.5%, to $373,354 from $1,523,284 in the prior comparable period. The decrease is a result of the change in fair value of the contingent consideration related to the CorHepta transaction from December 31, 2025 to February 21, 2026, the date the service milestone was satisfied and the contingent liability settled.
Current wording
Change in fair value contingent consideration decreased by $1,642,757, or 81.5%, to $373,354 from $2,016,111 in the prior comparable period. The decrease is a result of the change in fair value of the contingent consideration related to the CorHepta transaction from December 31, 2025 to February 21, 2026, the date the service milestone was satisfied and the contingent liability settled.
Previous wording
Other income increased by $1,084,817, or 59.1%, to $2,920,843 from $1,836,026 in the prior comparable period. The increase was driven by interest earned on our cash, cash equivalents and marketable securities.
Current wording
Other income increased by $2,008,447, or 75.1%, to $4,682,566 from $2,674,119 in the prior comparable period. The increase was driven by interest earned on our cash, cash equivalents and marketable securities.
Previous wording
From our inception up until our December 2020 initial public offering, we funded our operations primarily through private, state and federal contracts and grants. In October 2024, we raised approximately $99.6 million in net proceeds from a private placement and in November 2025, we raised approximately $107.6 million in net proceeds from our underwritten public offering.
Current wording
From our inception up until our December 2020 initial public offering, we funded our operations primarily through private, state and federal contracts and grants. Since our initial public offering, we have funded operations through public offerings and sales under our ATM program. In October 2024, we raised approximately $99.6 million in net proceeds from a private placement and in November 2025, we raised approximately $107.6 million in net proceeds from our underwritten public offering.
Previous wording
On June 20, 2025, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC, as sales agent ("Jefferies"), pursuant to which we may, from time to time, issue and sell shares of our common stock through or to Jefferies. Under the terms of the Sales Agreement, Jefferies may sell the shares of our common stock at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended. As of December 31, 2025, no shares of our common stock had been sold under the Sales Agreement. In February 2026, we sold 1,904,762 shares of common stock pursuant to the Sales Agreement for an aggregate gross sales price of $3.0 million. In July 2026, we sold 25,261,500 shares of our common stock pursuant to the Sales Agreement for aggregate gross proceeds of $50.5 million.
Current wording
On June 20, 2025, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC, as sales agent ("Jefferies"), pursuant to which we may, from time to time, issue and sell shares of our common stock through or to Jefferies. Under the terms of the Sales Agreement, Jefferies may sell the shares of our common stock at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended. As of December 31, 2025, no shares of our common stock had been sold under the Sales Agreement. During the first nine months of 2026, we sold 27,166,262 shares of common stock pursuant to the Sales Agreement for an aggregate net proceeds of $52.0 million, including 25,000,000 shares sold to RA Capital Management.
Previous wording
At June 30, 2026, we had cash, cash equivalents and marketable securities of $159.0 million.
Current wording
At September 30, 2026, we had cash, cash equivalents and marketable securities of $193.3 million.
Previous wording
We have incurred recurring losses and at June 30, 2026 had an accumulated deficit of $178.7 million.
Current wording
We have incurred recurring losses and at September 30, 2026 had an accumulated deficit of $199.1 million.
Previous wording
To date, we have not generated any revenue from the sale of commercial products. We do not expect to generate any significant revenue from product sales unless and until we obtain regulatory approval of and successfully commercialize any of our product candidates and we do not know when, or if, this will occur at all. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for our lead product candidate, IKT-001, and begin to commercialize any future approved products which we may in-license or develop. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Current wording
To date, we have not generated any revenue from the sale of commercial products. We do not expect to generate any significant revenue from product sales unless and until we obtain regulatory approval of and successfully commercialize any of our product candidates and we do not know when, or if, this will occur at all. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to significantly increase as we continue the development of, and seek regulatory approvals for our lead product candidate, IKT-001, and begin to develop and commercialize any future approved products which we may in-license or develop. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Previous wording
Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, if ever, we expect to finance our incremental cash needs through a combination of equity offerings, debt financings, working capital lines of credit, and potential licenses and collaboration agreements. Additional working capital may not be available timely or on commercially reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts on a timely basis or on terms acceptable to us, we may have to significantly delay, reduce or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing stockholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term but limit our potential cash flow and revenue in the future. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Current wording
Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, if ever, we expect to finance our incremental cash needs through a combination of equity offerings, debt financings, working capital lines of credit, and potential licenses and collaboration agreements. Additional working capital may not be available timely or on commercially reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts on a timely basis or on terms acceptable to us, we may have to significantly delay, reduce or discontinue the development or commercialization of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing stockholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term but limit our potential cash flow and revenue in the future. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Previous wording
Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $178.7 million at June 30, 2026. We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.
Current wording
Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $199.1 million at September 30, 2026. We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.
Previous wording
We believe that our existing cash, cash equivalents and marketable securities as of June 30, 2026, will enable us to fund our operating requirements for at least the next twelve months following the date of this Quarterly Report. We estimate that the additional capital raised through our sale of common stock through our ATM in July 2026, together with our cash and cash equivalents and marketable securities as of June 30, 2026 will support operations through topline data readout in Part B of our ongoing global Phase 3 IMPROVE-PAH clinical study, assuming the full and timely exercise of the outstanding Series A and B Warrants. However, we have based these estimates on assumptions that may prove to be mistimed or wrong, and we could deplete our working capital sooner than planned.
Current wording
We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2026, will enable us to fund our operating requirements for at least the next twelve months following the date of this Quarterly Report. We estimate our cash and cash equivalents and marketable securities as of September 30, 2026 will support operations through topline data readout in Part B of our ongoing global Phase 3 IMPROVE-PAH clinical study, assuming the full and timely exercise of all of the outstanding Series A and B Warrants and provided our product development efforts meet projected timelines. However, we have based these estimates on assumptions that may prove to be mistimed or wrong, and we could deplete our working capital sooner than planned.
Previous wording
the timing and progress of preclinical and clinical development activities;
Current wording
the timing and progress of nonclinical and clinical development activities;
Previous wording
the number and scope of preclinical and clinical programs we pursue;
Current wording
the number and scope of nonclinical and clinical programs we pursue;
Previous wording
the costs and ongoing investments to in-license and/or acquire additional technologies; and
Current wording
the costs and ongoing investments to in-license and/or acquire additional product candidates or other technologies; and
Previous wording
possible delays or interruptions to preclinical studies, clinical trials, our receipt of services from our third-party service providers on whom we rely, or our supply chain due to epidemics or pandemics.
Current wording
possible delays or interruptions to nonclinical studies, clinical trials, our receipt of services from our third-party service providers on whom we rely, or our supply chain due to epidemics or pandemics.
Previous wording
Net cash flows used in operating activities for the six months ended June 30, 2026, totaled $24,503,334, and consisted primarily of a net loss of $36.0 million adjusted for non-cash stock compensation of $10.9 million, a decrease in the fair value of contingent consideration of $0.4 million, non-cash accretion on marketable securities of $2.0 million, an increase in accounts payable and accrued expenses and other current liabilities of $5.0 million, an increase in prepaid expenses and other current assets of $0.6 million, an increase in prepaid research and development of $1.3 million, and an increase in other assets of $0.1 million.
Current wording
Net cash flows used in operating activities for the nine months ended September 30, 2026, totaled $41,855,564, and consisted primarily of a net loss of $56.4 million adjusted for non-cash stock compensation of $16.4 million, a decrease in the fair value of contingent consideration of $0.4 million, non-cash accretion on marketable securities of $3.2 million, an increase in accounts payable and accrued expenses and other current liabilities of $7.7 million, an increase in prepaid expenses and other current assets of $1.1 million, an increase in prepaid research and development of $4.8 million, and an increase in other assets of $0.1 million.
Previous wording
Net cash flows used in operating activities for the six months ended June 30, 2025, totaled $9,677,761, and consisted primarily of a net loss of $23.6 million adjusted for non-cash stock compensation of $6.3 million, a write-off of in-process research and development of $7.4 million, a decrease in the fair value of contingent consideration of $1.5 million, an increase in accounts payable of $1.6 million, an increase in accrued expenses and other current liabilities of $0.3 million and a net decrease in other operating assets and liabilities of $0.1 million.
Current wording
Net cash flows used in operating activities for the nine months ended September 30, 2025, totaled $20,270,491, and consisted primarily of a net loss of $35.5 million adjusted for non-cash stock compensation of $10.8 million, a write-off of in-process research and development of $7.4 million, a decrease in the fair value of contingent consideration of $2.0 million, noncash accretion on marketable securities of $0.6 million, a decrease in accounts payable of $0.4 million, an increase in prepaid research and development of $1.1 million, an increase in accrued expenses and other current liabilities of $1.0 million and a decrease in other assets of $0.3 million and a decrease in other liabilities of $0.1 million.
Previous wording
Net cash flows used in investing activities for the six months ended June 30, 2026, totaled $86,393,289, of which $59.2 million was provided by maturity of marketable securities and $145.6 million was used for the purchase of marketable securities.
Current wording
Net cash flows used in investing activities for the nine months ended September 30, 2026, totaled $99,003,803, of which $122.3 million was provided by maturity of marketable securities and $221.3 million was used for the purchase of marketable securities.
Previous wording
Net cash flows provided by investing activities for the six months ended June 30, 2025, totaled $30,898,080, of which $31.4 million was provided by maturity of marketable securities and $0.4 million related to acquired in-process research and development associated with the CorHepta acquisition discussed above.
Current wording
Net cash flows provided by investing activities for the nine months ended September 30, 2025, totaled $2,151,977, of which $41.6 million was provided by maturity of marketable securities, $39.0 million was used for the purchase of marketable securities and $0.4 million related to acquired in-process research and development associated with the CorHepta acquisition discussed above.
Previous wording
Net cash flows provided by financing activities for the six months ended June 30, 2026, totaled $2,883,122, which consisted of net proceeds from the issuance of common stock in connection with the Sales Agreement with Jefferies.
Current wording
Net cash flows used in financing activities for the nine months ended September 30, 2025, totaled $102,359, which consisted of $0.3 million of net proceeds from the issuance of common stock related to the exercise of stock options and $0.4 million of deferred offering costs in connection with the Sales Agreement.
Previous wording
We previously leased office space in Lexington, Massachusetts under an operating lease that expired on September 30, 2025. As of June 30, 2026, we have no remaining lease obligations under this arrangement. We received a refund of our security deposit in July 2026. The refund is not expected to have a material impact on our liquidity or results of operations.
Current wording
We previously leased office space in Lexington, Massachusetts under an operating lease that expired on September 30, 2025. As of September 30, 2026, we have no remaining lease obligations under this arrangement. We received a refund of our security deposit in July 2026. The refund did not have a material impact on our liquidity or results of operations.
Previous wording
We have entered into various agreements with contract research organizations ("CROs") and contract manufacturing organizations ("CMOs") to support our ongoing Phase 3 clinical study, IMPROVE-PAH, as well as related manufacturing activities. We may also need CMOs for redundancy and to support commercial production, if we achieve regulatory approval for IKT-001. These agreements generally include both fixed and variable components and, in certain cases, are non-cancelable or subject to termination fees.
Current wording
We have entered into various agreements with contract research organizations ("CROs") and contract manufacturing organizations ("CMOs") to support our ongoing single pivotal Phase 3 clinical study, IMPROVE-PAH, as well as related manufacturing activities. We may also need other CMOs for manufacturing redundancy and to support commercial production, if we achieve regulatory approval for IKT-001. These agreements generally include both fixed and variable components and, in certain cases, are non-cancelable or subject to termination fees.
Previous wording
As of June 30, 2026, our estimated remaining contractual commitments under these arrangements, excluding performance-based milestone payments, were approximately $106.6 million for CRO services and $9.8 million for CMO services, which we expect to incur primarily through 2030. The timing of these expenditures is dependent on several factors, including patient enrollment rates, clinical site activation, and manufacturing production schedules.
Current wording
As of September 30, 2026, our estimated remaining contractual commitments under these arrangements, excluding performance-based milestone payments, were approximately $107.6 million for CRO services and $8.7 million for CMO services, which we expect to incur primarily through 2030. The timing of these expenditures is dependent on several factors, including patient enrollment rates, clinical site activation, and manufacturing production schedules.
Previous wording
A portion of our CRO commitments includes performance-based milestone payments, of which approximately $7.5 million of the total contracted value is contingent upon the achievement of specified criteria by the vendor. The timing and likelihood of these payments are uncertain and depend on the progress and outcomes of the clinical trial. While one milestone of $0.4 million has been achieved to date, the remaining milestones are not currently considered probable and, accordingly, are not reflected in our accrued liabilities as of June 30, 2026.
Current wording
A portion of our CRO commitments include performance-based milestone payments, of which approximately $7.5 million of the total contracted value is contingent upon the achievement of specified criteria by the vendor. The timing and likelihood of these payments are uncertain and depend on the progress and outcomes of the clinical trial. While one milestone of $0.4 million has been achieved to date, the remaining milestones are not currently considered probable and, accordingly, are not reflected in our accrued liabilities as of September 30, 2026.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Cash Provided by (Used In) Financing Activities